Application 081318

Type: ANDA
Sponsor: ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	JELLY;TOPICAL	2%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A081318-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL			1993-04-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A081318-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	1993-04-29	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 16 · 308 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	23c8f711-e458-479a-9ab0-dcc851311e24	2026-09-10	Warnings, Adverse reactions	Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Viscous	LIDOCAINE HYDROCHLORIDE	REMEDYREPACK INC.	6f8d20d2-6a91-4a5b-bfe8-f1baada38442	2026-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
XYLOCAINE MPF	LIDOCAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	1986c302-82a0-95a9-e063-6294a90a3339	2026-09-02	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	9920daef-b156-4a14-b641-f714191ffb5c	2026-09-02	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	REMEDYREPACK INC.	f824b48c-7039-4ce1-b3df-b3597aba5beb	2026-08-28	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
HUSTLE BUTTER NUMBING	LIDOCAINE HYDROCHLORIDE	H.B.D. D.I.S.T. INC.	d7dfb312-6c80-4a2d-b8b2-d9891cb0b74e	2026-08-24	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	ad1ef0a8-88db-4648-c098-d009eaeb4e5b	2026-08-20	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Major Pharmaceuticals	04e8dd94-93a8-427d-81ab-a95793d86c36	2026-08-18	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
CVS Pain Relief Roll-On Lidocaine with Lavender	LIDOCAINE HYDROCHLORIDE	CVS Pharmacy	4aa53176-2103-b47b-e063-6394a90ac735	2026-08-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine	LIDOCAINE HYDROCHLORIDE	Sentiss Pharmaceuticals LLC	9b2d4f69-0c84-4956-b5c0-b4410acf62e0	2026-08-12	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Tattoo Wipe	LIDOCAINE HYDROCHLORIDE	MD Tattoo Company	369c1d16-597c-e1dc-e063-6394a90a3104	2026-08-06	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	3b2dd84e-cee8-4e58-d494-395a65a353a0	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hospira, Inc.	9c18eaf1-4a0b-4916-70b2-88a827494711	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	YYBA CORP	582a0001-da1e-909a-e063-6394a90a2b11	2026-08-03	Warnings	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	46404c7b-2ea4-e47b-e063-6294a90a779f	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Xylocaine MPF	LIDOCAINE HYDROCHLORIDE	Sportpharm LLC	50aa6133-0776-4714-9821-fe8581f635ca	2026-07-28	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Aspercreme Lidocaine with Rosemary and Mint	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	9d40bfea-85d0-4943-83e9-0c16e79a011c	2026-07-28	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
AEROBURN	LIDOCAINE HYDROCHLORIDE	Aero Healthcare US LLC	f8fa72db-5f7a-4158-a2b3-f8bc0e12df9f	2026-07-24	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
AEROBURN	LIDOCAINE HYDROCHLORIDE	Aero Healthcare US LLC	a32cbc19-ec30-4634-b70d-664f2a2edd95	2026-07-24	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	573a7298-b02e-230c-e063-6294a90a269c	2026-07-22	Warnings, Adverse reactions	Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.